Creatine Phosphokinase (CPK)

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K780504 ↗

FDA Product Code

JHS

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Potassium

  Class II

  FDA 510(k) K771837 Active Cleared 2 Nov 1977

• Calcium

  Class II

  FDA 510(k) K771831 Active Cleared 25 Oct 1977

• Chloride

  Class II

  FDA 510(k) K771832 Active Cleared 22 Nov 1977

• Sodium

  Class II

  FDA 510(k) K771839 Active Cleared 2 Nov 1977

• Gamma Smac Reagents

  Class II

  FDA 510(k) K790578 Active Cleared 15 May 1979

• Total Protein

  Class II

  FDA 510(k) K771841 Active Cleared 25 Oct 1977

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• What is the primary function of the Creatine Phosphokinase (CPK) device?

  This device serves as a diagnostic reagent designed to assist clinical laboratories in the analysis of enzyme levels within patient samples. It utilizes a differential rate kinetic method to measure CPK or specific isoenzymes.

• What is the regulatory classification of this CPK reagent?

  The device is classified as a Class 2 medical device under regulation number 862.1215. It received FDA 510(k) clearance under submission number K780504, which determined it to be substantially equivalent to existing devices.

• Which medical specialty is this device associated with?

  This device is categorized under the Clinical Chemistry medical specialty. It is intended for use in laboratory settings to support the quantitative analysis of clinical chemistry markers.